Frank Willford Email and Phone Number
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As a hands-on, senior-level chemical engineer I have over 16 years’ experience in process design, development, and improvement in heavily regulated industries. Throughout my career, I have led innovative projects to support process development, qualification, validations, technology transfers, regulatory submissions, and commercial implementations.Data-driven, I employ solid engineering and project management skills to turn detailed information into actions. Self-motivated, I support strategic initiatives and build relationships with multicultural, cross-functional groups in regulated environments. Additional applicable skills and competencies:• New Technology Implementation and Hypothesis Testing• Project Management, Procurement, and Supply Chain Operations • Quality Control Engineering and Assurances• High-Volume Production and Quality Systems• Data Visualization and Change Management• Risk Analysis ((Failure Mode Effects Analysis-FMEA)• Regulatory Rules, Filings & Guidelines (Medical Devices & Vaccinations)• Microsoft Project and Office (Word, Excel, PowerPoint & Outlook) • Verbal & Written Communications and Basic ComputingStatistical tools, techniques, and Lean methodologies include:-JMP -Statistical Process Control (SPC) -Six Sigma DMAIC and Kaizen-Minitab-Good Automation Manufacturing Practice (GAMP)
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Process / Validation EngineerTechnical Source Oct 2024 - PresentRaleigh, Nc, Us
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Validation EngineerThermo Fisher Scientific Jun 2022 - Jun 2023Waltham, Ma, UsValidation of a new downstream single-use chromatography skid to support Thermo Fisher's CMO organization and for commercial clients. Provide subject matter expertise to design and lead validation/qualification of a strategic new pharmaceutical introduction. -
Validation EngineerInnovative Labs Mar 2021 - Jun 2022Springville, Utah, UsFostering and developing a more robust company-wide equipment qualification and process validation program. Generates necessary documentation that pertains to the qualification of equipment and critical utilities. Coordinating the scheduling of validation protocol executions and testing with company Departments and personnel. -
Delivery DriverJla Rapid Delivery Nov 2020 - Mar 2021
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Project Manager / EngineerMilliporesigma Nov 2015 - Jun 2019Burlington, Ma, UsResponsible for capital project life cycles including initiation, managing scope, budgeting, procurement of contractors, materials & equipment, scheduling, and closure documentation. Lead capital projects for fire suppression systems, manufacturing equipment, and other instruments necessary to support chemical processing and contract manufacturing.Conduct fire suppression upgrades for powered buffers manufacturing, small equipment, and other instruments needed to support any contract manufacturing.• Manage the commissioning, validation, and closeout for Clean-in-Place (CIP) pump skids, compact vertical foil packaging machines (tablet packagers), powder transfer systems, and Clean-Out-of-Place (COP) skids. -
Validation Engineer-ContractedQualicaps Jun 2015 - Nov 2015Whitsett, North Carolina, UsPrepared project plans with milestones and timelines using the GAMP V-Method as a model. Authored qualification documents including a URS/FRS/DS document, OQ protocol and a traceability matrix.• Facilitated upgrades to gelatin capsule manufacturing by leading the qualification and validation of InfinityQS ProFicient Statistical Process Control (SPC) software that monitored viscosity of liquid gelatin. -
Manufacturing Support Engineer-(Contracted By Novartis)Yoh, A Day & Zimmermann Company Sep 2012 - Jun 2015Philadelphia, Pa, UsContracted by Novartis Vaccines to provide engineering support for the process qualification and validation of a new Quadri-valent seasonal flu vaccine to meet market demand. • Expedited the process development, qualification, and validation of the bulk downstream purification process and final formulation in support of the monovalent pandemic H5N1 for Phase III clinical trials and H7N1 bulk drug substances and initial site licensure for the trivalent seasonal flu vaccine. -
Staff EngineerMerck Sharp & Dohme Dec 2010 - Sep 2012Led technology transfer of a critical viral vaccine stabilizing buffer. Conducted engineering batch, managed change control, developed processing procedures, and set process parameters to maintain Critical Quality Attributes (CQAs).• Developed a re-dispense process for intermediate stock solutions. Worked with operations, technology, and quality departments to implement new processes in a bulk manufacturing facility.
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Technology Engineer IvWyeth Biotech Oct 2005 - May 2009New York, New York, UsWorked on new process development, validation, and regulatory submission. Provided engineering support and project management assistance on the design, development, validation, and regulatory submission of a new disposable closed-system sterile filling process that saved $50 million in facility capital upgrades and fulfilled an international regulatory commitment. Assisted the project manager with developing plans, estimating a capital budget and establishing a cross-functional team to develop major milestones and timelines. Worked with outside vendors and manufacturing personnel to design a disposable closed system filling process.• Supported the technology transfer of a product storage container integrity test which reduced product loss by more than 50%. Support included identifying and purchasing equipment, planning and executing engineering studies, analyzing data using JMP statistical software and establishing integrity testing parameters and procedures.• Collaborated with research & development on the use of an optically-based dissolved oxygen probe to control microbial fermentation batches. Designed and executed Design of Experiments (DoE) studies to determine the robustness of newly dissolved oxygen probes and optimal fermentation parameters. -
Technology Engineer IiiWyeth Vaccines Research Sep 2003 - Oct 2005Pearl River, Ny, UsLaunched process and equipment improvement projects and pilot scale process development.• Collaborated with manufacturing departments and support groups to implement equipment and procedure improvements to ensure a plentiful, consistent, and reliable supply of vaccines. Improvements reduced product losses by $60 million within the first two years of implementation.• Led a scaled-down purification operation for a 13-valent Prevnar vaccine process to ensure a more efficient polysaccharide production. Trained and coached employees in ultra & depth filtration, diafiltration, HA ion exchange, chromatography, and 0.22pm sterile filtration unit operations. Assisted with the development of polysaccharide fermentation and centrifugation processes. -
Development EngineerKelly Engineering Resources Aug 2002 - Sep 2003Troy, Michigan, UsManufacturing Process Development -
Chemical/Environmental EngineerDynamac Corporation Nov 1998 - Jul 2002Four years experience in solid and hazardous waste management, RCRA and CERCLA investigation, environmental engineering analysis and federal environmental regulation.
Frank Willford Skills
Frank Willford Education Details
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Brigham Young UniversityChemical Engineer
Frequently Asked Questions about Frank Willford
What company does Frank Willford work for?
Frank Willford works for Technical Source
What is Frank Willford's role at the current company?
Frank Willford's current role is Providing innovative quality engineering to improve products and processes..
What is Frank Willford's email address?
Frank Willford's email address is fw****@****ail.com
What is Frank Willford's direct phone number?
Frank Willford's direct phone number is +191955*****
What schools did Frank Willford attend?
Frank Willford attended Brigham Young University.
What are some of Frank Willford's interests?
Frank Willford has interest in Science And Technology.
What skills is Frank Willford known for?
Frank Willford has skills like Technology Transfer, Process Simulation, Vaccines, Validation, Six Sigma, Process Improvement, Gmp, Change Control, Leadership, V&v, Purification, Quality By Design.
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